Ohio State University’s Wexner Medical Center has started to perform a procedure that swaps bad
bacteria for good in patients with a gut infection that sickens 337,000 people in the United States
each year and kills 14,000.

Dr. Razvan Arsenescu, an OSU gastroenterologist, said he has performed two bacterial
transplants, which have a 95 percent success rate in treating the deadly “superbug”
Clostridium difficile, known as
C. diff.

C. diff infections have become a major problem in hospitals and nursing homes in Ohio and
across the United States. Although more and more physicians are beginning to perform these
transplants nationwide, the U.S. Food and Drug Administration might slow things down as it
considers regulatory oversight.

The procedure, which transfers good bacteria in a fecal transplant, treats the infection that
can cause diarrhea, fever and other symptoms. The disease usually is picked up in health-care
facilities or from antibiotics, which can disrupt the normal bacteria in the bowel.

“I’ve known about (fecal transplant) for a long time, but it wasn’t yet developed as a protocol”
at Ohio State, said Arsenescu, medical director of the Inflammatory Bowel Disease Clinic there. “It
took us six to eight months to discuss it with the institution. It’s a lot of commitment on many
levels to be able to do this.”

There, doctors perform the procedure during a colonoscopy, transplanting donor fecal matter in a
saline solution.

The FDA recently began to discuss regulating the transplants and now requires doctors to fill
out a new-drug application before performing them.

FDA spokesman Curtis Allen said the agency held a workshop in May to discuss fecal transplants.
He said a number of physicians voiced concerns that regulations could slow down the care of
patients.

Dr. R. David Shepard, a gastroenterologist with a practice in Tampa, Fla., said he has performed
more than 30 fecal transplants with a 100 percent success rate. But he said he stopped when the FDA
announced it would require new-drug applications because he doesn’t have the staff to handle the
increased paperwork.

“It can take weeks or months to get these (applications) approved — we have sick patients,”
Shepard said. “I find it very troubling considering the number of people who are dying from
C. diff.”

Now, Shepard assists patients in his office or over the phone with self-administered
transplants. “At home, it may not be as effective — they may need more treatment — but it’s better
than doing nothing,” he said. “I’m hoping it’s not going to take that long for the FDA to see the
risk of this practice is almost zero and the benefits are well-documented.”

No adverse effects from fecal transplants have been reported in the short term, but there is
little data on the long-term effects, said Cliff McDonald, a senior adviser for science and
integrity at the Centers for Disease Control and Prevention.

The Cleveland Clinic has performed six transplants in the past two years. Dr. John Vargo,
chairman of the department of gastroenterology and hepatology, said the success rate has been 100
percent.

“I do believe it’s going to have a tremendous effect on the patients with recurrent
C. diff,” he said.

Antibiotics, such as vancomycin, are now the first line of treatment, but fecal transplants
might take their place, Arsenescu said.

Kim Brinkman, 42, of Ashland, got the infection in May 2012 after taking an antibiotic for a
throat infection. The preschool teacher said she suffered from diarrhea, exhaustion and fever.

“I would be fine one second and then have to run to the bathroom the next,” Brinkman said. “
There were times it was so bad I couldn’t go anywhere or do anything.”

She was treated at OSU last month. A friend, Sarah Rivenburgh, was the donor. Brinkman said she
noticed an improvement within three days.

“I wish I didn’t have to go through a whole year of feeling how I’ve felt,” she said. “You just
have faith that the antibiotic will take care of it. … When that didn’t happen, I looked for other
options.”

The procedure is performed on an outpatient basis, and colonoscopies usually are covered by
insurance. Patients are charged about $800 to $1,000 for testing the feces before transplant.

Arsenescu said he plans to look into what other conditions or infections fecal transplants might
treat, including inflammatory bowel disease.